Pacific Edge Updates Billing Policies for US Testing

3 July 2023
PACIFIC EDGE UPDATES BILLING POLICIES FOR US TESTING
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) today
announces an update to its billing policies in the US for Cxbladder tests.
From 17 July 2023, Pacific Edge will provide for enhanced patient responsibility where a patient’s
insurer declines to pay for a Cxbladder test. Pacific Edge will also update its Patient Assistance Program
to assist lower income patients with making their bill more affordable.
The new process requires all patients not covered by a contracted health insurer to be informed by the
ordering physician of the patient’s responsibility when ordering the test. All patients will be required to
sign an Advance Beneficiary Notice of Non-Coverage (ABN). They will also be encouraged to complete
a Patient Assist form as part of the test ordering process. Where a patient’s sample is received without
ABN and Patient Assist forms, customer service agents will contact the patient to obtain complete
information before the test is processed.
The Enhanced Patient Responsibility approach follows the finalization in early June of a Local Coverage
Determination (LCD)
1
that could see Medicare coverage of Cxbladder tests cease on 17 July 2023.
Medicare and Medicare Advantage tests represented ~60% of commercial Cxbladder tests performed
in the year to 31 March 2023, accounting for 77.7% of Operating Revenue.
Pacific Edge Chief Executive Dr Peter Meintjes said: “Despite the determination by Novitas, thousands
of urologists across the US and around the world share our view that Cxbladder offers clinically valuable
and actionable information. This information can improve the standard of care for patients suspected of
or previously affected by bladder cancer, can offer improved patient management options for
physicians, and spare patients from unnecessary invasive urinary tract examinations.
“When clinicians explain to patients that a Cxbladder test may allow them to safely avoid a cystoscopy,
we expect many will accept some patient responsibility for payment if their insurer declines to cover the
test”.
“While the impact on demand for our tests in the US is uncertain, we expect the new approach to
improve collections in the event of denial from any non-contracted insurer, including Medicare and make
some contribution to revenues after 17 July.”
Released for and on behalf of Pacific Edge by Grant Gibson Chief Financial Officer.
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263


1
Novitas, the Medicare Administrative Contractor with jurisdiction for Pacific Edge’s US laboratory finalized the LCD (L39365)
on 2 June 2023 noting that Cxbladder tests were not ‘not considered medically reasonable and necessary’, the threshold
required for coverage under the US Social Security Act

OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way in the
development and commercialization of bladder cancer diagnostic and prognostic tests for patients
presenting with hematuria or surveillance of recurrent disease. Headquartered in Dunedin, New
Zealand, the company provides its suite of Cxbladder tests globally through its wholly owned, and CLIA
certified, laboratories in New Zealand and the USA.
Cxbladder: www.cxbladder.com
Cxbladder is a urine-based genomic biomarker test optimized for the detection and surveillance of
bladder cancer. The Cxbladder evidence portfolio developed over the past 14 years includes more than
20 peer reviewed publications for primary detection, surveillance, adjudication of atypical urine cytology
and equivocal cystoscopy. Cxbladder is the focal point of numerous ongoing and planned clinical
studies to generate an ever-increasing body of clinical utility evidence supporting adoption and use in
the clinic to improve patient health outcomes. Cxbladder has been trusted by over 4,400 US urologists
in the diagnosis and management of more than 100,000 patients, including the option for in-home
sample collection. In New Zealand, Cxbladder is accessible to 75% of the population via public
healthcare and all residents have the option of buying the test online.